WEBSTER F6QF252RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835008012), received between Oct 14, 2024 and Oct 14, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 14, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL TACHYCARDIA ABLATION PROCEDURE WITH A WEBSTER AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS AND DRAIN PLACEMENT. IT WAS REPORTED THAT DURING AN ATRIAL TACHYCARDIA CASE, A PERICARDIAL EFFUSION WAS NOTICED. THE PHYSICIAN NOTICED WHEN GOING TRANSSEPTAL THAT THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGES DIDN¿T LOOK THE WAY THEY SHOULD. THIS CAUSED THEM TO NOTICE THE DROP IN BLOOD PRESSURE SO THEY CHECKED FOR ANY COMPLICATIONS. NO ABLATION HAD BEEN COMPLETED WHEN THE INJURY OCCURRED. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ICE. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS. THE PATIENT FULLY RECOVERED, HOWEVER, REQUIRED EXTENDED HOSPITALIZATION (PATIENT HAD TO SPEND 2 NIGHTS IN THE HOSPITAL WAITING FOR THE DRAIN TO BE REMOVED AND WATCHING TO MAKE SURE SHE WAS COMPLETELY RECOVERED). THE PHYSICIAN BELIEVED THE RV WAS PERFORATED USING THE QUAD CATHETER DURING THE TRANSSEPTAL PUNCTURE BECAUSE THE EFFUSION WAS BIGGER ON THE RIGHT SIDE OF THE HEART.

  Patient problems: Cardiac Tamponade

  MAUDE report 20447496 ↗